Last updated: 11/03/2018 15:07:08
alcohol interaction study
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A study to investigate the psychomotor and cognitive effects of alcohol when co-administered with GSK1144814 or matching placebo in healthy subjects.
Trial description: The purpose of this study is understand the effects of GSK114814 and alcohol in healthy volunteers when taken together.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
pharmacodynamic measures for various psychomotor/cognition function and subjective effects
Timeframe: pre and post study drug administration
Secondary outcomes:
alcohol level
Timeframe: during and post alcohol administration
blood level of GSK1144814
Timeframe: pre and post study drug administration
safety and tolerability as measured by adverse events, vital signs, clinical laboratory measurements and validated clinical assessment scales
Timeframe: throughout the study pre- and post dose
Interventions:
Drug: single dose
Enrollment:
21
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
te Beek ET, Hay JL, Bullman JN, Burgess C, Nahon KJ, Klaassen ES, Gray FA, van Gerven JMA. Central nervous system effects of the novel dual NK1/NK3 receptor antagonist GSK1144814 in alcohol-intoxicated volunteers. Br J Clin Pharmacol. 2012;75(5):1328-1339.
Medical condition
Alcoholism
Product
GSK1144814
Collaborators
Not applicable
Study date(s)
November 2009 to December 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Healthy male and female
- Body weight 50 kg or higher and BMI within the range 19 – 29.9 kg/m2
- Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody result
- Any serious medical disorder or condition
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy male and female
- Body weight 50 kg or higher and BMI within the range 19 – 29.9 kg/m2
- Willing to use appropriate contraception methods
Exclusion criteria:
- Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody result
- Any serious medical disorder or condition
- Any history of an endocrine disorder.
- Any clinically significant laboratory abnormality.
- History of psychiatric illness.
- Any history of suicidal attempts or behavior.
- Positive urine drug screen or positive blood alcohol
- Pregnant, nursing or potential to have a child
- Past history of alcohol dependence or abuse.
- History of increased sensitivity to the effects of alcohol or violent behaviour/aggression when intoxicated.
- smokers
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-30-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study 113476 can be found on the GSK Clinical Study Register.
Click hereAccess to clinical trial data by researchers
Visit website